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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic video imaging system/component, gastroenterology-urology
Regulation Description Endoscope and accessories.
Definition To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
Product CodeFET
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
FUJI
  SUBSTANTIALLY EQUIVALENT 1
GIMMI GMBH
  SUBSTANTIALLY EQUIVALENT 1
GREATBATCH SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 15
MEDLINE
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 6
PENTAX
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 4
SCHOLLY FIBEROPTIC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOPRO
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No display or display failure 12
Bacterial contamination of device 8
Poor quality image 5
Circuit Failure 4
Device operates differently than expected 4
No Known Device Problem 4
Loss of power 3
Failure to power-up 2
Image display error 2
Erratic display 2
Artifact 2
Break 2
Burn of device or device component 2
Spark 2
Device damaged prior to use 2
Residue after decontamination 2
High test results 1
Arcing 1
Electrical power problem 1
Failure to auto stop 1
Infusion or flow issue 1
Connection issue 1
Optical distortion 1
Power source issue 1
No code available 1
Electrical issue 1
Fire 1
Fracture 1
Grounding malfunction 1
Excess flow or overinfusion 1
Moisture damage 1
Overheating of device or device component 1
Reflux within device 1
Inappropriate shock 1
Total Device Problems 76

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Fujifilm Medical Systems U.S.A., Inc. II Sep-22-2015
2 Karl Storz Endoscopy II Jul-06-2016

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